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الخميس - صفر 27, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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SA-23-10-24-643
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
AK 98 hemodialysis machines
الأجهزة المتأثرة
Product Code: 955603 Product Description : AK 98V3 230V BIO VERSION Serial Numbers: All serials with runtime less than 500 hours Product Code: 955604 Product Description : AK 98V3 230V SELF-CARE Serial Numbers: All serials with runtime less than 500 hours
الممثل المعتمد
Baxter AG
سبب المشكلة
the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices. The source of the NDL PCBAs and/or NDL PCBs in those recalls was due to the manufacturing process of the silicone tubing, which used a chlorinated peroxide initiator.
الإجراء التصحيحي
Do not stop dialysis treatment to patients who need it. When the new platinum-cured silicone tubing components for AK 98 machines become available, Baxter will contact you to determine whether there is a need to correct or replace your existing devices. For more info, Kindly see the attachment.
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